Regulatory Open Forum

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  • 1.  Orphan Drug Designation Review Times

    Posted 04-Nov-2013 14:27
    FDA Orphan Drug Designation Holders--

    Will you please share how long (initial submission to notification) it took FDA to complete the review of your application?
     
    Thanks.
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    William Tubbs
    Director, Regulatory Affairs and Quality Assurance
    Promedior, Inc.
    Lexington MA
    United States
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  • 2.  RE:Orphan Drug Designation Review Times

    Posted 04-Nov-2013 17:36
    I know of one that took 2 months, 2 days from submission to designation (was in 2012).

    ______________________________________________
    Michael A. Swit, Esq.
    Special Counsel, FDA Law Practice
    Duane Morris LLP
    750 B Street, Suite 2900
    San Diego, CA 92101-4681
    P: +1 619 744 2215
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    maswit@duanemorris.com

    Note: all postings by me on this forum represent my personal views and are not necessarily those of my clients or my law firm. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

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    Original Message


  • 3.  RE:Orphan Drug Designation Review Times

    Posted 05-Nov-2013 08:16

    Hi William,

    I have submitted quite a few orphan drug designation requests to the FDA.  The typical response time has ranged between 60 and 90 days.
    I once searched all of the prohan drug information on the FDA website and found no information about the timing for their response to orphan designation requests.  So I called the agencyand asked about that.  The response I received was that there was not a set review time or even a formal target but that they tried to aim for 60 days as an informal target.  In my experience they have responded within 60 to 90 days, as I said.

    Best regards,
    Kathy
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    Kathryn Wekselman
    Director, Regulatory and Scientific Affairs
    CTI Clinical Trial and Consulting Services
    Cincinnati OH
    United States
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    Original Message


  • 4.  RE:Orphan Drug Designation Review Times

    Posted 06-Nov-2013 08:39
    Hello.
    The FDA is tracking several metrics on their FDA-TRACK website.
    One of the metrics is the number of orphan drug applications reviewed in 90 Days or less.
    Their stated goal is 75 percent of applications reviewed in 90 Days or less.
    The data is current through March of 2013: http://www.accessdata.fda.gov/FDATrack/track?program=osmp&id=OSMP-OOPD-Percentage-orphan-drug-designation-reviewed-completed-in-90-days-or-less

    Best.
    Mike 

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    Michael Curtis PhD
    SVP, Product Development and Regulatory Affairs
    Catabasis Pharmaceuticals
    Cambridge MA
    United States
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    Original Message